Cleared Traditional

K133033 - HIDREX PSP1000

K133033 is an FDA 510(k) clearance for HIDREX PSP1000, manufactured by Hidrex GmbH. The device is a Class 2 Physical Medicine device with product code EGJ cleared through the Traditional 510(k) pathway after a 559-day FDA review.

K133033 · Hidrex GmbH · Physical Medicine device
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Apr 2015
Decision
559d
Days
Class 2
Risk

K133033 is an FDA 510(k) clearance for the HIDREX PSP1000. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Hidrex GmbH (Texas City, US). The FDA issued a Cleared decision on April 8, 2015 after a review of 559 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Hidrex GmbH devices

FDA 510(k) Submission Details - K133033

510(k) Number K133033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2013
Decision Date April 08, 2015
Days to Decision 559 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
444d slower than avg
Panel avg: 115d · This submission: 559d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGJ Device Classification - Class 2, Special Controls

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - EGJ Device, Iontophoresis, Other Uses

All 32
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K133033.
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